Aethlon Medical Introduces HER2osome™, A Novel Therapeutic Device Strategy to Address Breast Cancer

SAN DIEGO, Sept. 21, 2011 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today the introduction of HER2osome™, a novel medical device strategy to inhibit the progression of HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein.  Breast cancer represents the most common form of invasive cancer in women. HER2+ breast cancer accounts for approximately 25% of new breast cancer diagnosis.

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The goal of HER2osome™ therapy is to simultaneously reduce the circulatory presence of HER2 protein and breast cancer exosomes, which have increasingly become recognized as playing pivotal role in the development and progression of breast cancer.  Researchers report that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin (trastuzumab), a leading monoclonal antibody treatment against the HER2+ breast cancer.  As an adjunct therapeutic candidate, HER2osome™ offers to address an unmet medical need and enhance the benefit of Herceptin and standard of care chemotherapies without adding drug toxicity or interaction risks.  

To support the pre-clinical and clinical advancement of HER2osome™, Aethlon has submitted a funding proposal entitled, "An Innovative Device Strategy to Eliminate HER2 Breast Cancer Progression" to the Breast Cancer Research Program (BCRP) offered through the Assistant Secretary of Defense for Health Affairs, Defense Health Program. The BCRP was established in fiscal year 1992 (FY92) to support innovative research focused on eradicating breast cancer. Appropriations for the BCRP from FY92 through FY10 totaled over $2.5 billion. The FY11 appropriation is $150 million.  Principal investigators underlying the Aethlon BCRP funding proposal are Dr. CS Chen, Chief, Division of Hematology and Oncology and Medical Director of the Loma Linda Cancer Center, and Dr. Douglas Taylor, Professor, Department of Obstetrics & Gynecology at University of Louisville School of Medicine.

The evolution of HER2osome™ therapy is based upon an adaptable dialysis-like affinity platform technology known as the Aethlon ADAPT™ system.  Therapies evolved from the Aethlon ADAPT™ system target the selective clearance of harmful agents from the entire blood volume within clinically relevant time frames and without the loss of essential blood components. Thus, overcoming the historic limitation of extracorporeal strategies that indiscriminately adsorb or remove particles solely by molecule size. In function, the device platform allows the immobilization of single or multiple affinity agents in the outer-capillary space of plasma filtration membrane technology as a means to provide rapid real-time clearance of corresponding targets.  In the case of HER2osome™, the immobilization of a HER2 antibody and an exosome targeted affinity agent provides a mechanism to clear both targets from the circulatory system of HER2+ breast cancer patients.  Like all ADAPT™ derived therapies, HER2osome™ will operate dialysate free, will not require replacement fluids, and can be utilized on dialysis machines or CRRT systems already located in hospitals and clinics worldwide.

Aethlon has previously leveraged its ADAPT™ system through a proposal chosen for funding through a DOD contract award under DARPA-BAA-11-30 entitled "Dialysis-Like Therapeutics".  The proposed program, which is pending completion of a contracting phase, would support the development of a therapeutic device that reduces the incidence of sepsis in wounded warfighters through the selective clearance of circulating septic precursors.  

The genesis of the ADAPT™ system is the Hemopurifier®, a device that immobilizes a single lectin affinity agent to provide broad-spectrum capabilities against viral pathogens and immunosuppressive proteins. Human studies have demonstrated the Hemopurifier® to be safe and provide average viral load reductions of greater than 50% during four-hour treatment periods in both hepatitis-C (HCV) and HIV infected individuals without the administration of antiviral drugs.  The device is currently the subject of a human clinical study to evaluate its ability to accelerate viral load depletion when utilized in combination with HCV standard of care drug therapy.  An investigational device exemption (IDE) to initiate clinical studies in the United States has been submitted to The Food and Drug Administration (FDA).

In vitro studies recently documented that the Hemopurifier® also captures exosomes underlying cancer, including colorectal, lymphoma, melanoma, ovarian, and breast cancer. On August 24^th, Aethlon expanded its exosome research programs through a collaborative agreement with the Sarcoma Oncology Center (SOC), based in Santa Monica, California. The SOC collaboration will study the ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients.  The study will evaluate 25 patients, five patients with metastatic cancer of the following types; non-small cell lung cancer, prostate cancer, melanoma, head and neck cancer, and sarcoma.  Exosomes released by cancers have emerged to become an important therapeutic target in cancer care, as they are implicated in cancer survival, growth, and metastasis.  Researchers have also identified that cancer-released exosomes may assist tumors in evading the response of the immune system.  

About Aethlon Medical

The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Aethlon's ADAPT™ platform provides the technology foundation for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Hemopurifier®, a first-in-class medical device with broad-spectrum capabilities against exosomes that contribute to the progression of cancer and infectious viral pathogens such as HIV and Hepatitis C.  For more information, please visit www.aethlonmedical.com.

Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.  Such potential risks and uncertainties include, without limitation, the ability to demonstrate ex vivo effectiveness of the Aethlon Hemopurifier®, the Aethlon ADAPT™ System, or the HER2osome™ to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients, future therapeutic trials in cancer patients, future human studies of the Hemopurifier®, the Aethlon ADAPT™ System, or the HER2osome™ as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier®, the Aethlon ADAPT™ System, or the HER2osome™ ability to capture exosomes and the impact it may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.

Contacts:

James A. Joyce
Chairman and CEO
858.459.7800 x301
[email protected]

Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
[email protected]

Jim Frakes
Chief Financial Officer
858.459.7800 x300
[email protected]

John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
[email protected]

SOURCE Aethlon Medical, Inc.